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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04265261
Registration number
NCT04265261
Ethics application status
Date submitted
5/02/2020
Date registered
11/02/2020
Date last updated
17/01/2024
Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
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Scientific title
A Randomized, Double-Masked, 48-Week, Parallel-Group, Placebo-Controlled, Proof-of-Concept Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
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Secondary ID [1]
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2019-002067-10
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Secondary ID [2]
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BP41321
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Universal Trial Number (UTN)
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Trial acronym
CANBERRA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetic Retinopathy
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - RG7774
Placebo Comparator: Group A - Participants will receive an oral dose of placebo matched to RG7774 once daily (QD)
Experimental: Group B - Participants will receive a low oral dose of RG7774 QD
Experimental: Group C - Participants will receive a high oral dose of RG7774 QD
Treatment: Drugs: Placebo
Participants will receive oral placebo matched to RG7774
Treatment: Drugs: RG7774
Participants will receive oral RG7774
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Participants with >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) from Baseline at Week 36 Measured in the Study Eye
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Assessment method [1]
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Timepoint [1]
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Week 36
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Primary outcome [2]
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Percentage of Participants with Adverse Events (AEs)
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Assessment method [2]
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Timepoint [2]
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From baseline up to 52 weeks
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Secondary outcome [1]
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Percentage of Participants with Anterior Segment Neovascularization (ASNV), new Proliferative Diabetic Retinopathy (PDR), new Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention
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Assessment method [1]
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Timepoint [1]
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From baseline up to 52 weeks
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Secondary outcome [2]
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Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
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Assessment method [2]
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Timepoint [2]
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Baseline; Week 36
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Eligibility
Key inclusion criteria
Inclusion Criteria
- Able and willing to provide written informed consent and to comply with the study
protocol according to International Conference of Harmonization (ICH) and local
regulations
- Male and female patients of at least 18 years of age
- Treatment naïve with moderately severe to severe NPDR defined as ETDRS DRSS 47 or 53
- Patients are eligible with and without DME in either eye
- BCVA score at screening of at least 70 letters in study eyes without DME and at least
75 letters in case DME is present
- Clear ocular media and adequate pupillary dilation to allow acquisition of good
quality retinal images.
- Diagnosis of diabetes mellitus (DM) type 1 or type 2
- Hemoglobin A1c (HbA1c) </= 12%.
- A female is eligible to participate if she is not pregnant, not breastfeeding
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
Ocular criteria for study eye:
- Prior treatment for DR or other retinal diseases with any approved or investigational
therapy, including but not limited to intravitreal steroids, intravitreal anti-VEGF,
light therapy, periocular pharmacological intervention, and laser (e.g. focal, grid,
micropulse, or pan-retinal)
- Uncontrolled glaucoma
- Any concurrent intraocular condition (e.g. retinal detachment, dense cataract,
epiretinal membrane with traction, or vitreomacular traction, etc.) that in the
opinion of the Investigator could reduce the potential for improvement, require
medical surgical intervention or may confound the visual and functional assessment and
interpretation of study results
Concurrent ocular conditions in either eye:
- Any active ocular infection
- Any active intraocular inflammation
General Criteria:
- Previous systemic use of anti-VEGF drugs within 6 months prior to screening
- Complications of diabetes such as end-stage renal disease or liver disease
- Currently untreated diabetes mellitus or previously untreated patients who initiated
oral or injectable anti-diabetic medication within 3 months prior to screening
- Uncontrolled blood pressure ([BP] defined as systolic > 180mmHg and/or diastolic >100
mmHg while patient at rest)
- History of concurrent cardio-vascular disease not considered well controlled by the
Investigator
- Any major illness or major surgical procedure within one month before screening
- History of or currently active other diseases, metabolic dysfunction, physical
examination finding, malignancies not considered cured, or clinical laboratory
findings giving reasonable suspicion of a condition that contraindicated the use of
the investigational medicinal drug or that might affect interpretation of the results
of the study or renders the patient at high risk for treatment complications in the
opinion of the investigator
- Known hypersensitivity to any of the excipients of the drug used, fluorescein dye or
dilating eye drops
- Use of systemic medications known to be toxic to the lens, retina or optic nerve
(e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and
ethambutol) used during the 6-month period prior to screening or likely need to be
used
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/07/2023
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Sample size
Target
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Accrual to date
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Final
104
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Sydney Eye Hospital - Sydney
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Recruitment hospital [2]
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Sydney Retina Clinic and Day Surgery - Sydney
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Recruitment hospital [3]
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Centre For Eye Research Australia - East Melbourne
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Recruitment hospital [4]
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Retina Specialists Victoria - Rowville
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment postcode(s) [3]
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3178 - Rowville
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Georgia
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Illinois
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Banska Bystrica
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Zilina
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Barcelona
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Belfast
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Colchester, Essex
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Guilford
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Sunderland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The study's main purpose is to asses the safety, tolerability, and effect of oral
administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with
moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04265261
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04265261
Download to PDF